Field of the Invention
The present invention relates to a reaction container, a nucleic acid analysis device including the reaction container, and a nucleic acid analysis method.
Description of the Related Art
“Order-made (personalized) medicine” that provides an effective treatment and an effective medication method depending on a genetic background which a patient has on the basis of epidemiological and scientific grounds is expected not only to improve QOL (quality of life) of each individual, but also to suppress an increase of medical expenses along with side effects of drugs. Various techniques are present in determining the effects or the side effects of the drugs, but a gene diagnosis that analyzes differences of genes between individuals is one of the effective techniques. It is preferable that the order-made (personalized) medicine be capable of making a simple and quick diagnosis in the field. As a technique for realizing a simple and quick diagnosis, a technology which is referred to as μ-TAS (Total Analysis System) being a reaction device which deals with a very small amount of a sample solution containing the gene, or Lab-on-Chip is used.
This is a device including a plurality of reaction chambers and flow paths in one chip or one cartridge, and can deal with analyses of a plurality of analytes, or a plurality of types of items at the same time. These technologies are techniques having various advantages such that it is possible to make the handled drugs into a small amount by miniaturizing the chip and the cartridge. An outline of a gene analysis has processes of taking out nucleic acid by extracting or purifying the nucleic acid for the gene analysis from a biological sample such as blood, oral mucosa or sputum which is collected from the patient, amplifying a gene region to be examined and a nucleic acid sequence to be examined by PCR or the like, and detecting a specific sequence in a check target such as a genotype.
In Japanese Unexamined Patent Application, First Publication No. 2004-212050, Japanese Unexamined Patent Application, First Publication No. 2004-093297, and Clinical Chemistry 51: 882-890, 2005, a gene diagnosis device in which processes such as amplification and detection proceed in a fully automatic manner after nucleic acid is taken out from a biological sample is disclosed.
When the process of extracting the nucleic acid is independent from the subsequent processes of amplifying and detecting, it is possible to confirm the amount of the nucleic acid by an operation using an external device. However, in the device which is disclosed in Japanese Unexamined Patent Application, First Publication No. 2004-212050, Japanese Unexamined Patent Application, First Publication No. 2004-093297, and Clinical Chemistry 51: 882-890, 2005, the processes of amplifying and detecting proceed in a fully automatic manner after the nucleic acid is extracted from the biological sample, and it is not possible to confirm the amount of the obtained nucleic acid. Therefore, the amount of the nucleic acid taken out is unclear, and it is not sufficient in a case where the check target is aimed at detecting gene mutation or the like.
For example, in the case of gene mutation which is represented by cancer or the like, when 99.9% in total is normal wild type, and it is desired to detect a variant of the remainder of 0.1%, it is not possible to secure that the mutation is 0.1% unless the amount of the nucleic acid necessary before the amplifying is 1000 copies or more.
Moreover, it is considered that when an irregular result is output in the analysis of the presence and absence of a particular nucleic acid sequence or gene polymorphism, it is not possible to differentiate whether the amount of the nucleic acid is insufficient or a phenomenon is caused by mixing a reaction inhibition material or the like into a system.
In this manner, there is a case where the amount of the nucleic acid is unclear in a fully automatic gene analysis system, and reliability of the analysis result depends on properties of the check items.
The present invention is made in consideration of the above circumstances, and an object thereof is to provide a reaction container that is suitably used in a fully automatic gene analysis system and capable of quantifying nucleic acid obtained by extraction from a biological sample, and capable of analyzing the nucleic acid, a nucleic acid analysis device including the reaction container, and a nucleic acid analysis method.